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Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

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ClinicalTrials.gov Identifier: NCT03683849
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mikkel Jacobi Thomsen, Aalborg University

Brief Summary:
This study evaluates physiological measurements and their role in among falls in healthy elderly (65yr or older) or elderly suffering from osteoporosis. The study further seeks to evaluate if dancing can be used as training for preventing falls.

Condition or disease Intervention/treatment Phase
Osteoporosis Fall Injury Other: Training Not Applicable

Detailed Description:
This study seeks to examine the relationship between strength, postural control and bone mineral density on the risk of falling among elderly (65 yr or older). The study will carried out on osteoporosis patients and healthy, matched controls. The study further seeks to examine whether a dancing intervention may improve any of these parameters, resulting in a decreased risk of falling.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dancing as Training Method for Fall Preventing in Patients Suffering From Osteoporosis
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Osteoporosis

Arm Intervention/treatment
Experimental: Dancing group
Dance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months.
Other: Training
One hour of training, twice a week, for six months.

Active Comparator: Strength training group
Strength training group. Training will be administered for an hour twice a week, for six months.
Other: Training
One hour of training, twice a week, for six months.

No Intervention: Control
Control group



Primary Outcome Measures :
  1. Falls [ Time Frame: Changes from baseline at 6- and 18 months ]
    Number of falls


Secondary Outcome Measures :
  1. Postural stability [ Time Frame: Changes from baseline at 6- and 18 months ]
    Postural sway measured using a high resolution three-dimensional force platform

  2. Pain intensity rating: McGill Pain Questionnaire [ Time Frame: Changes from baseline at 6- and 18 months ]
    Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable), indicating pain areas on a body chart and filling out a McGill Pain Questionnaire

  3. Physical Activity [ Time Frame: Changes from baseline at 6- and 18 months ]
    Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire

  4. Fitness assessment [ Time Frame: Changes from baseline at 6- and 18 months ]
    Evaluation of fitness using the Fullerton Functional Fitness Assessment. The test is a 6-item test. The score in each of the six tests is assessed separately and will not be used to provide a total score of the six tests.

  5. Dynamical balance assessment [ Time Frame: Changes from baseline at 6- and 18 months ]
    Evaluation of the dynamical balance using the Mini-Balance Evaluation Systems Test (Mini-BESTest), which is a 14-item test, scored on a 3-level ordinal scale. The scale ranges from 0-28, with a higher score representing better dynamical balance.

  6. Bone mineral density [ Time Frame: Changes from baseline at 18 months ]
    Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.

  7. Gait variability [ Time Frame: Changes from baseline at 6- and 18 months ]
    Kinematic analysis of gait, recorded using the Xsens system

  8. Cognitive function [ Time Frame: Changes from baseline at 6- and 18 months ]
    A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient groups

Inclusion Criteria:

  • Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray absorptiometry scanning (DXA)
  • Receiving medical treatment for osteoporosis

Exclusion Criteria:

  • Drug addiction defined as the use of cannabis, opioids or other drugs.
  • Use of medical cannabis.
  • Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
  • Lack of ability to cooperate.
  • Osteoporosis grade higher than moderate or severe (T-score < -3.5)

Healthy elderly groups

Inclusion Criteria:

• T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)

Exclusion Criteria:

  • Drug addiction defined as the use of cannabis, opioids or other drugs.
  • Use of medical cannabis.
  • Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
  • Lack of ability to cooperate.
  • Osteoporosis grade higher than mild, moderate or severe (T-score < -2.5)
  • Receiving medical treatment for osteoporosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683849


Contacts
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Contact: Mikkel Jacobi Thomsen, PhD. stud. 4599403713 mjt@hst.aau.dk

Locations
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Denmark
SMI, Aalborg University Recruiting
Aalborg, Denmark, 9100
Contact: Mikkel Jacobi Thomsen, PhD fellow         
Sponsors and Collaborators
Aalborg University
Investigators
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Principal Investigator: Mikkel Jacobi Thomsen, PhD. stud. Aalborg University

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Responsible Party: Mikkel Jacobi Thomsen, Principal Investigator, Aalborg University
ClinicalTrials.gov Identifier: NCT03683849     History of Changes
Other Study ID Numbers: MJT.PhD.2018-2021
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases